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Sunday, July 08, 2018 1:26:06 PM
In his remarks, Curtis Jensen left the door open for a CE Mark regulatory approval that may not require human trials. He said something to the effect of “We will submit our technical file to the EU with porcine and cadaver trials, and we will have human trials underway for FDA should the EU come back and ask for those.”
Reading between the lines, this means we could possibly see approval and launch in Europe earlier than the US.
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